BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 23534378 · Received November 12, 2025

    Report

    Report Number
    1000113657-2025-00407
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 12, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(6): USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-OCT-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 267, 353, 161, 191 AND 220 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE BELOW 160 MG/DL AM FASTING AND BELOW 170 MG/DL 2 HOURS POST MEAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER ADVISED THAT SHE CALLED HER DOCTOR'S OFFICE THAT MORNING BECAUSE SHE FELT THAT THE METER WAS NOT ACCURATE. CUSTOMER WAS NOT HAVING ANY SYMPTOMS WHEN SHE CALLED HER DOCTOR. NO INSTRUCTIONS PER THE CUSTOMER WERE GIVEN TO HER ON MEDICATION/DIET CHANGES FROM THE DOCTOR'S OFFICE. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2027 AND TEST STRIPS WERE OPENED 2-3 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 267 MG/DL DATE: (B)(6) 2025 TIME: 9:30 AM FASTING RESULT 2: 353 MG/DL DATE: (B)(6) 2025 TIME: 9:03 AM FASTING RESULT 3: 161 MG/DL DATE: (B)(6) 2025 TIME: 7:05 PM 2 HRS. AFTER MEAL RESULT 4: 191 MG/DL DATE: (B)(6) 2025 TIME: 9:08 AM FASTING RESULT 5: 220 MG/DL DATE: (B)(6) 2025 TIME: 9:00 AM 2 HRS. AFTER MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592871 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZD6125S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other